FDA-Device2016-09-21Class II
Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months.
Mentor Texas, LP.
Hazard
The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
Sold states
Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium
Affected count
48 units
Manufactured in
3025 Skyway Cir N, N/A, Irving, TX, United States
Products
Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2780-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief